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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS MESH SOFRADIM - UGYTEX¿ MESH, SURGICAL, POLYMERIC

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SOFRADIM PRODUCTION SAS MESH SOFRADIM - UGYTEX¿ MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number UGY1510
Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Patient Problems Incontinence (1928); Inflammation (1932); Itching Sensation (1943); Pain (1994); Injury (2348); Prolapse (2475); Blood Loss (2597); Fibrosis (3167); No Code Available (3191)
Event Type  Death  
Manufacturer Narrative

(b)(4). If information is provided in the future, a supplemental report will be issued.

 
Event Description

The patient's attorney alleged a deficiency against the device resulting in an unspecified adverse outcome. Product was used for therapeutic treatment. The preoperative and postoperative diagnosis was pelvic pain. The procedure performed was a removal of prior sacrocolpopexy and placement of a new sacrocolpopexy mesh. The patient underwent an additional procedure on (b)(6) 2016. The preoperative and postoperative diagnosis was stress urinary incontinence. The procedure performed was a cystoscopy with regular transvaginal tape sling. At this time a gynecare tvt was implanted. The patient has experienced incontinence, blood loss, prolapse, pain, itching, shaking, fibrosis, inflammation, fragments of mesh, additional surgical interventions. New information indicates patient is deceased. The death certificate indicates the immediate cause breast cancer, neutropenia, septic shock and multiorgan failure (natural causes is checked on the death certificate). There was no indication that a bard product contributed to her death.

 
Manufacturer Narrative

(b)(4). If information is provided in the future, a supplemental report will be issued.

 
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
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Brand NameMESH SOFRADIM - UGYTEX¿
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
SOFRADIM PRODUCTION SAS
116 avenue du formans
trevoux 01600
FR 01600
Manufacturer (Section G)
SOFRADIM PRODUCTION SAS
116 avenue du formans
trevoux 01600
FR 01600
Manufacturer Contact
lisa hernandez
60 middletown ave
north haven, CT 06473
2034925563
MDR Report Key7635086
MDR Text Key112228857
Report Number9615742-2018-01358
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK033376
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation ATTORNEY
Type of Report Initial,Followup,Followup
Report Date 10/04/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/25/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/30/2013
Device MODEL NumberUGY1510
Device Catalogue NumberUGY1510
Device LOT NumberPIG00588
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/08/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 06/25/2018 Patient Sequence Number: 1
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